Come October 1, Indian pharma exporters will be obligated to fix bar codes on exported medicines, as per notification issued by the Directorate General of Foreign Trade issued January this year. Exporters of pharma products will adopt a trace and track system and incorporate its features for exported medicines using bar code technology as per GS1 global standards. The GS1 Identification keys are GTIN which is Global Trade Item Number for the Products or Services. The SSCC known as Serial Shipping Container Codes is for Individual Logistics Units. The GLN (Global Location Numbers) is for Physical Locations and Legal Entities.

Barcode obligation is something no exporter would ignore to ensure growth in the overseas market. But it involves financial commitment. They don’t have to worry too much. The government is coming to their rescue. Union Ministry of Micro Small and Medium Enterprises (MSME) have allocated Rs.75 crore to the pharmaceutical sector for the implementation of bar codes.

As per details released, under the financing scheme, the government has stated that for the one time registration fee, it would provide 75 per cent of assistance only to the Small and Medium Enterprises (SMEs). There are various slabs for identifying the registration fees based on the stock keeping units (SKUs). For instance, SKUs between 0 to 100, the registration fee is Rs.50, 000. For 100 to 1,000 it would be around Rs.65, 000 and so on.

The DGFT Public Notice and Ministry of Health & Family Welfare have three phases for implementation. The first phase is for the Tertiary Level Packaging which begins from October 1, 2011 onwards. The phase II which is for Secondary Level Packaging begins on January 1, 2012. The phase III for Primary Level Packaging commences from July 1, 2012.

In order to comply with the DGFT requirements, there is need to generate GTINs for all packaging levels the company prefix number as per the procedure. Therefore the first Barcode will have the GTIN with Expiry Date and Batch No. The second bar code will have the SSCC. The GTIN 13 has 13 digits. The company prefix item number will always add up to 12 digits. The 13th digit is the Check Digit.

It is reliably learnt that SMEs from the pharmaceuticals, Ayurveda and Homoeopathy drug production segment have already begun to seek the assistance. In order to get the full benefit of the assistance from the government the MSME Development Institute in Bangalore has now teamed-up with the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) to identify the units which would require the assistance as MSME is keen to offer the bar codes in bulk to fulfill the execution requirements, V V Prasad, assistant director, MSME Development Centre, Ministry of MSME, according to media reports.

Barcode mechanism, according to Siemens, is critical for life science industries because it improves supply chain security and patient safety. “Track and trace solutions are not just economic measures for supply-chain efficiency. Experts estimate that 5% of all drugs sold worldwide are counterfeits – in some countries, figures even reach a shocking 50 %. Billions of products are “lost in the supply chain” every year. Counterfeit drugs and product diversion risk lives, undermine revenues, and threaten company reputations. The pharmaceutical industry needs to ensure supply-chain security and gain the ability to authenticate the ePedigree, or life history, of a product,” according to Siemens website.

Track and trace solutions are an essential part of this strategy. Track and trace solutions identify the origins of a pharmaceutical industry product and verify its authenticity. Moreover, track and trace solutions also help combat product diversion, whereby legitimate products are diverted from one market to another, with implications for licensing obligations and distribution agreements as well as for revenues, it adds.